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临床试验/NCT01971372
NCT01971372已完成不适用

Comparing Methods of NSAID Delivery for Postoperative Pain

University of Oklahoma1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2013年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Pain scores

研究概览

简要总结

Specific Aim 1: To identify differences in pain perception and satisfaction with pain control in women undergoing urogynecologic surgery receiving nonsteroidal anti-inflammatory (NSAIDS) postoperatively by oral ibuprofen, intravenous ibuprofen, or intravenous ketorolac. Specific Aim 2: To compare the differences in narcotic usage and medication side effects.

详细描述

All patient will be informed that they may receive either ibuprofen or ketorolac and that the medication may be given (IV) or per os (PO). Patients were also informed that their pain may improve or worsen during the study, and that they could request additional pain medication (as a rescue medication) at any time.

After surgery, all patients will be placed initially on a patient controlled analgesia (PCA) of hydromorphone with standardized settings of allowing the patient to dispense 0.2 mg of medication every 6 minutes (lockout rate) and an hourly maximum of 2.0 mg/hour. A one-time nursing bolus of 0.4 mg will also be ordered. The PCA will be discontinued on the morning after surgery no later than 12:00 noon. The patient will then be started on PO pain medication, either hydrocodone/acetaminophen or oxycodone/acetaminophen.

Immediately after surgery, patients will then be assigned to one of three treatment arms with a computer-generated randomization schedule that is to be based on their order of enrollment. Patients were informed they could withdraw at any point. Three visual analog scores (VAS) will be obtained from the patient before noon on the first day after surgery. One scale to assess pain at rest, one scale to assess pain with ambulation, and one scale to assess satisfaction with pain control.

The medications will each be given every 8 hours in order to keep all medications on a similar doing regimen. This will allow the patients to receive a total of three doses of medication over 24 hours, regardless of which arm of the study they are randomized to.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female gender
  • Available for reliable follow up
  • Able to complete study assessment
  • Scheduled for surgery by FPMRS surgeon

排除标准

  • Age <18 years
  • Known renal impairment
  • Congestive heart failure
  • Dementia or inability to follow instructions
  • Allergy to NSAIDS
  • Allergy to hydromorphone
  • History of gastrointestinal bleeding or ulceration
  • Inflammatory bowel disease

结局指标

主要结局

Pain scores

时间窗: Within 24 hours after surgery

Three visual analog scores (VAS) will be obtained from the patient before noon on the first day after surgery. One scale to assess pain at rest, one scale to assess pain with ambulation, and one scale to assess satisfaction with pain control.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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